WHO guidelines for assessing

WHO guidelines for assessing quality of herbal medicines

with reference to contaminants and residues

WHO Library Cataloguing-in-Publication Data

WHO guidelines for assessing quality of herbal medicines with reference to contaminants and residues. 1. Medicine, Herbal - standards. 2. Quality control. 3. Drug contamination. 4. Chemistry, Analytical. 5. Guidelines. I. World Health Organization.

ISBN 978 92 4 159444 8

(NLM classification: QV 766)

? World Health Organization 2007

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Printed in Spain

Contents

Contents

Acknowledgements ..................................................................................................... v

Foreword ....................................................................................................................... vii

Preface .......................................................................................................................... ix

1. Introduction ........................................................................................................... 1 1.1 Background ......................................................................................................... 1 1.2 Purpose and objectives ...................................................................................... 2 1.3 Use of the document .......................................................................................... 3 1.4 Glossary .............................................................................................................. 4 1.4.1 Terms relating to herbal medicines............................................................. 4 1.4.2 Terms relating to contaminants and residues

in herbal medicines ................................................................................... 6

2. Potentially hazardous contaminants and residues in herbal medicines ...................................................................................... 11

2.1 General considerations ...................................................................................... 11 2.2 Chemical contaminants ..................................................................................... 13 2.2.1 Toxic metals and non-metals ....................................................................... 13 2.2.2 Persistent organic pollutants ....................................................................... 13 2.2.3 Radioactive contamination .......................................................................... 13 2.2.4 Mycotoxins and endotoxins ........................................................................ 14 2.2.5 Solvents occurring as contaminants ........................................................... 14 2.3 Biological contaminants .................................................................................... 15 2.3.1 Microbiological contaminants ..................................................................... 15 2.3.2 Parasitic contamination................................................................................ 15 2.4 Agrochemical residues ...................................................................................... 15 2.4.1 Pesticide residues .......................................................................................... 15 2.4.2 Extraneous pesticide residues .................................................................... 17 2.5 Residual solvents................................................................................................ 17

3. Guiding principles for assessing safety of herbal medicines with reference to contaminants and residues .............................................. 19

3.1 General approach ? compliance with good practice guidelines ................. 19 3.2 Foreign matter..................................................................................................... 19 3.3 Contaminants...................................................................................................... 19 3.3.1 Arsenic and toxic metals .............................................................................. 19 3.3.2 Persistent organic pollutants ....................................................................... 20 3.3.3 Radioactive contaminants............................................................................ 20 3.3.4 Microbial toxins............................................................................................. 20 3.3.5 Microbiological contaminants ..................................................................... 20 3.4 Residues............................................................................................................... 21 3.4.1 Pesticide residues .......................................................................................... 21

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WHO guidelines for assessing quality of herbal medicines with reference to contaminants and residues

3.4.2 3.4.3

Extraneous pesticide residues .................................................................... 22 Residual solvents........................................................................................... 22

4. Recommended analytical methods .................................................................... 23 4.1 Determination of arsenic .................................................................................. 24 4.2 Determination of radioactive contaminants................................................... 25 4.3 Determination of aflatoxins .............................................................................. 26 4.4 Determination of microbiological contaminants ........................................... 27 4.5 Determination of pesticide residues................................................................ 28

5. References............................................................................................................... 33 Annex 1 List of participants in the WHO consultation on contaminants

and residues in herbal medicines, Milan-Loveno di Menaggio, Italy, 12?14 July 2004..................................................................................... 37

Annex 2 General technical notices ............................................................................. 41

Annex 3 Determination of arsenic and toxic metals................................................ 47

Annex 4 Determination of aflatoxins ......................................................................... 55

Annex 5 Determination of microorganisms.............................................................. 59

Annex 6 Determination of pesticide residues........................................................... 69

Annex 7 List of culture media and strains used for microbiological analysis..................................................................... 85

Annex 8 List of reagents and solutions...................................................................... 89

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